Trials / Completed
CompletedNCT02324309
BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Biodel · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIOD-531 | |
| DRUG | Humalog Mix 75/25 | |
| DRUG | Humulin R U-500 | |
| DRUG | BIOD-531 |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-11-01
- First posted
- 2014-12-24
- Last updated
- 2016-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02324309. Inclusion in this directory is not an endorsement.